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Study of Aripiprazole (Abilify) Versus Placebo in Children With Subsyndromal Bipolar Disorder

This study has been completed.
Bristol-Myers Squibb
Information provided by (Responsible Party):
Robert L Findling, MD, University Hospital Case Medical Center Identifier:
First received: September 11, 2005
Last updated: December 17, 2014
Last verified: December 2014
The purpose of this study is to test the effectiveness and tolerability/safety of aripiprazole (abilify) in children with subsyndromal symptoms of bipolar disorder who also have a bipolar parent and other family member with a mood disorder.

Condition Intervention Phase
Bipolar Disorder
Other: Placebo
Drug: Aripiprazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Aripiprazole in At-Risk Children With Symptoms of Bipolar Disorder

Resource links provided by NLM:

Further study details as provided by University Hospitals Cleveland Medical Center:

Primary Outcome Measures:
  • Youth Mania Rating Scale (YMRS) [ Time Frame: 12 weeks ]
    The Young Mania Rating Scale (YMRS) has 11 items and is based on the patient's subjective report of his or her clinical condition over the previous 48 hours. Additional information is based upon clinical observations made during the course of the clinical interview. The items are selected based upon published descriptions of the core symptoms of mania. Each item o the YMRS is given a severity rating. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. There are well described anchor points for each grade of severity. Total score ranges from 0 to 60, with higher being more severe mania.

Enrollment: 59
Study Start Date: August 2004
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: placebo
Patients randomly assigned to placebo, a drug reduction schedule was generated so that the taper of medication occured over the course of the first 4 weeks of phase 2.
Other: Placebo
Addressed in arm description
Active Comparator: Aripiprazole
Patients randomly assigned to aripiprazole, attempts were made to keep doses of aripiprazole consistent during the course of phase 2.
Drug: Aripiprazole
Addressed in arm description
Other Name: Abilify

Detailed Description:

This will be a double-blind, placebo-controlled, parallel-arm, randomized clinical trial that will last up to 12 weeks.

This placebo-controlled portion will be followed by a 6-week open label extension/stabilization phase. In order to be eligible for participation in the extension/stabilization phase, subjects must: 1) in the investigator's opinion have had no dose-limiting side effects likely to be attributable to aripiprazole (APZ); 2) participated in the blinded portion of the clinical trial for a minimum of 4 weeks.


Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Outpatients ages 5-17 years (inclusive)
  • Patients, who in the investigator's opinion have substantial symptoms of mania, depression, or both within the past 2 weeks such that treatment with a pharmacological agent is warranted
  • Currently meets Diagnostic Statistical Manual of Mental Disorders (DSM-IV) criteria for either cyclothymia, or bipolar disorder not otherwise specified (BP NOS) based on the results of both a semi-structured diagnostic research assessment, Present and Lifetime Version (K-SADS-Present and Lifetime (PL) supplemented with sections from the WASH-U K-SADS) (Geller et al., 2001; Kaufman et al., 1997) and a clinical interview with a child and adolescent psychiatrist.
  • Offspring of a parent with a bipolar spectrum disorder (based on the results of either the Mini International Neuropsychiatric Interview (MINI)(Sheehan et al., 1998) or the Family History Method (FH-RDC)(Andreasen et al., 1977)
  • Has another first or second degree relative with a mood disorder determined by the results of either the MINI or the FH-RDC
  • Has participated in at least 4 sessions of psychotherapy specifically focused on the symptoms/management of pediatric mood disorder and continues to have clinically significant symptomatology

Exclusion Criteria:

  • Patients who have a history of intolerance to APZ at doses of 0.1mg/kg/day
  • Patients who have experienced a manic episode with documented treatment with APZ monotherapy at a dose of 0.2 mg/kg/day
  • Patients with an active neurological/medical disorder for which treatment with APZ would be contraindicated
  • Patients with clinical evidence of autistic disorder, Asperger's disorder, Rett's syndrome or other pervasive developmental disorder
  • Patients with clinical evidence of mental retardation
  • Patients who are known to be allergic or hypersensitive to aripiprazole
  • Patients who are unable to swallow pills/capsules
  • Patients for whom the need for hospitalization during the course of the study appears likely
  • Patients who have started a new psychotherapeutic intervention within less than 4 weeks of randomization
  • Patients who have a general medical or neurological condition (including clinically significant abnormalities on screening laboratories) that may be considered to be the etiology of the patient's mood disorder
  • Patients who have a general medical or neurological condition for which treatment with an atypical antipsychotic would be contraindicated (e.g. tardive dyskinesia)
  • Patients who have a general medical or neurological condition that could interfere with the interpretation of clinical response to APZ treatment
  • Patients taking psychotropic agents (other than psychostimulants) within one week of baseline (2 weeks for fluoxetine; 3 days for psychostimulants)
  • Patients with a suicide attempt requiring medical/psychiatric care within the past 6 months
  • Has met DSM-IV criteria for drug/alcohol abuse or dependence within the past 6 months
  • Females who are currently pregnant or lactating
  • Sexually active females, who in the investigators' opinion are not using an adequate form of birth control
  Contacts and Locations
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Please refer to this study by its identifier: NCT00194012

United States, Ohio
University Hospitals Case Medical Center - Walker Building
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Bristol-Myers Squibb
Principal Investigator: Robert L Findling, MD Johns Hopkins University
  More Information

Responsible Party: Robert L Findling, MD, Director, Division of Child and Adolescent Psychiatry, University Hospital Case Medical Center Identifier: NCT00194012     History of Changes
Other Study ID Numbers: At Risk
Study First Received: September 11, 2005
Results First Received: June 26, 2013
Last Updated: December 17, 2014

Keywords provided by University Hospitals Cleveland Medical Center:
bipolar disorder

Additional relevant MeSH terms:
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs processed this record on May 25, 2017